|Money for FDA’s Mission|
FDA always gets the attention of Congress when something goes wrong with one of the products it regulates. But, oddly, it gets less attention from Congress come budget time. In the past four years, it has not received much of an increase in its congressional budget appropriation. (This has been true during many other times in the agency's history as well.) User fees have filled some of the gap, but too much reliance on them leads to concerns that the agency is too beholden to industry. This is troubling, because to keep up with increasing costs, expanding science, changing technologies, and evolving missions, FDA's budget needs to grow.
Part of the problem is that there has rarely been a concerted lobbying effort on behalf of the agency—until now. FDA Alliance, formed last year, is a coalition of industry, researchers, patient and consumer groups, caregivers, and others. Their common goal is to urge Congress to give FDA the money it needs to carry out its mission. The organization now has more than 100 group and individual members.
In mid-July, the House Appropriations Subcommittee on Agriculture earmarked a 7.7% budget increase for FDA, but the $1.7 billion budget it gave to FDA fell short of FDA Alliance's proposal of $2 billion. The alliance called the increase insufficient.
The alliance tapped Steven Grossman as its executive director. He has been a health policy consultant since 1989, both with his own firm, HPS Group LLC, and with the firm Hill & Knowlton. He spoke with MD&DI editor-in-chief Erik Swain in June.
Q: How did FDA Alliance come to be? Who makes up the alliance?
A: I was approached about 18 months ago by a patient group and a research advocacy group and was asked to consider forming what became FDA Alliance. The two groups were concerned that FDA was not getting enough money to carry out its mission and stay ahead of the science—in other words, to get products to the market but to make sure that what gets on the market is safe. The two groups had spent a lot of time strengthening the National Institutes of Health (NIH; Bethesda, MD) and encouraging the pharma and bio industries to invest more in research, only to realize that FDA then needed more capacity to handle the results produced by these efforts.
In April 2006, we established a membership organization. Everyone pays their dues and members are listed publicly. [A membership list can be found at www.strengthenfda.org/members.htm.] The members run the gamut. There are consumer and patient organizations, research advocacy organizations, healthcare practitioners, trade organizations, companies, consulting firms, and individuals. Leading the list are six former FDA commissioners, each of whom had to fight these battles during their time with the agency. They are acutely aware of how difficult it is to get enough resources to do the job well.
Q: Why was there no FDA advocacy group until now?
A: There actually was a group in the early to mid-1990s. It eventually dissolved. It was not identical in structure or positioning, but the goal was the same: to be a voice for FDA resources. But other than that, FDA has not had an advocacy force that could draw attention to its needs.
FDA as a whole does not have a natural constituency. Compare it with NIH. There, all of the different professional societies in the different specialties, plus universities and other organizations, are interested in NIH's overall budget because of the grants it gives out and the interplay of scientific discovery between different disease areas. So they have organized together and have had a tremendous effect on the growth of NIH's budget allocations.
It is not the same case with FDA. Food, drugs, biotech, and medical devices are all regulated by FDA, but in different ways. There is no natural reason for these groups to be talking to each other. The nice thing is, when they've considered their stake in the larger FDA resource problems, they have given a very good response. Now, advocacy can be done in a more coordinated way. Not only are we a stronger force collectively, but many of FDA's budget restraints are systemic and not unique to any particular center.
Q: FDA has come under fire in recent years for its performance. That has given fuel to those who want to increase its budget. Did that climate have anything to do with the timing of the emergence of your group?
A: The current climate has been described as being shaky, but previous eras only seem more stable in retrospect. All commissioners experienced difficulties during their tenure and could have been more effective and more efficient with more resources.
What's really of significance in 2007 is what's happened to the budget in the last four years. FDA received additional money in the FY 2003 budget for counterterrorism in response to 9/11. The budget has gone up very little in the succeeding four fiscal years. A year ago, as we were just forming, we tried to observe and get a feel for the landscape. What I took away at that point was that no one asked the question, “Are we going to give the agency enough money to do its job well?” This year, a broad cross-sample of members of Congress have asked just this question. This is thanks in part to a lot of people's hard work in getting the word out that FDA's resources had fallen well below its mission requirements. The feedback we've received is very positive, with lots of concern now being expressed about whether the agency is getting enough money. That's what we need, instead of the attitude that FDA is just another slug in the budget.
Q: FDA's appropriation is bundled in with agriculture's and not the rest of HHS's. Is this why FDA tends to get forgotten at appropriations time? Can this appropriations structure ever change?
A: That FDA's budget is part of agriculture appropriations is an artifact that goes back to an earlier time when these things were looked at and organized differently. Is it likely to be changed to put FDA in the Labor and HHS appropriation? Probably not. What is important to us is identifying members of Congress who will be responsive to the agency's needs, particularly those on the agriculture subcommittee. But even if the jurisdiction were to be changed, the need for advocacy and for relationships with key lawmakers would not change.
Q: What kind of feedback have you gotten from Congress and from FDA and CDRH personnel?
A: Feedback from Congress has been overwhelmingly positive. We found that the FDA resource issue was something that members and staff hadn't been thinking about. When we brought the issue forward and put it into perspective, people responded to it. We changed the debate. Now the people who are concerned about FDA— members and staff—are the people who can do something about it.
We don't discuss FDA Alliance with FDA, even though we are advocates on behalf of its appropriation. We are careful as far as that goes—what little contact happens is strictly limited to questions of factual descriptions of programs and budget allotments. It is always about information that is publicly available. I assume the agency is pleased, but I don't know this to be true. We emphasize that we are doing this because we choose to, not because FDA has asked us to. It has not.
Q: Is CDRH's current budget enough to accomplish its mission? If not, what is not being done that should be?
A: Our recommendation is that the $230 million that CDRH will get in FY 2007 should be increased by $72 million. That $302 million is only the appropriation part. User fees are extra and above that, bringing the entire CDRH allotment to about $350 million. Clearly, there are things not being done that could be done. We think it's because the resources are not there.
In terms of particulars, that question was asked of the CDRH director [Daniel Schultz, during his presentation at the MDMA meeting in May]. He had already presented his and the Bush administration's priorities for CDRH. If more funding were available, he said, the priorities wouldn't change, but the center could start and finish them sooner. [The priorities Schultz cited included beefing up postmarket surveillance, improving the center's information technology, attracting more expertise to the review teams, and putting out more guidance.]
We will not substitute our judgment for FDA's as to what the priorities are. FDA officials are the ones who know how to protect the American people the best. They just need more resources to do it.
Q: How did the alliance arrive at the $302 million figure (plus user fees) for the CDRH budget?
A: We recommend an overall increase for FDA of $450 million, to take its non-user-fee budget from just more than $1.5 billion in FY 2007 to $2 billion in FY 2008. Again, user fees are additional. Over the past five years, CDRH's share of the non-user-fee, nonrent portion of the FDA budget has been about 17%. So the center was allotted that proportion of our proposed increase, and that was added to its FY 2007 budget. We arrived at the $2 billion number by looking at FDA's responsibilities and what it costs to keep the agency at a functional and effective level every year.
The FDA budget needs to grow about 5.8% every year to break even. On a $1.5 billion budget, adding $90 million is breaking even. Anything less than that starts costing jobs. We took the FY 2003 number, added this break-even amount plus congressional mandates, most of which are directed but not funded. When you add those amounts in, you get to about $2 billion, so that's what we're requesting. This is in many ways a catch-up budget request rather than an expansive budget request.
Q: What should CDRH do with the extra funds if it is able to get them?
A: We will defer in each case to FDA and its center directors as to where the money is best used. What we know is that every time FDA does not get enough money, personnel slots (and people) disappear. CDRH is going through this. People are asked to do two, three, or four jobs, and they are not doing any of them as well as they should. One of the reasons we are asking for more money is to get more people. It is not the sexiest thing to be asking for, but it is the most fundamental. About 83% of the budget supports things like salary, benefits, and transportation.
Second, the IT situation at FDA is in need of major overhaul. Ideally, the overhaul should start with the e-mail system and then move to databases and adverse-event tracking. There are a number of daunting challenges in this area that require substantial investment.
Q: Have user fees helped the CDRH budget situation? Should they be increased in the future?
A: User fees have helped, and they are now a permanent part of funding the agency. Our concern is not whether user fees grow, but whether the core functions of the agency are adequately funded—to which user fees are supposed to be additive.
But there have been unintended consequences of user fees. The way the law is structured sometimes puts the [user-fee] money into places that are not necessarily the highest priorities within FDA. These triggers need to be updated and reworded, which I believe is being done in the current legislation.
Q: CDRH launched an ambitious Postmarket Transformation Initiative recently. Does the center have the funds to execute it properly?
A: I have no specific knowledge of how much that system will need or from where the funds will come. But I do know that postmarket surveillance is a concern for many programs within FDA. In general, there are not enough funds in the current budget to get the level of postmarket safety capabilities to the level that Congress and the public want them. More money is needed. Postmarket surveillance should be an asset to the agency instead of a question mark. Also, the results of the surveillance need to reach people sooner.
Q: What is the long-range plan for your organization? Will it stick around if FDA gets the budget increase you advocate?
A: From the beginning, we have envisioned that it will take about five years to get FDA where it should be. Therefore, we see a long-range need for advocacy. Even if we get everything we want this year, there will be needs next year, especially given the increasing complexity of the products the agency regulates. For example, more devices are becoming parts of combination products, which means different technological issues must be addressed.
Also, FDA has been a global standard for regulation, and that benefits the United States. That needs to be maintained, and advocacy is needed for the funds and infrastructure to make this a continuing reality.
So, yes, we expect to be here, and we expect FDA to need an outside voice on its behalf. There has certainly been success with outside groups helping NIH. Yet, the battle never goes away, even when you succeed. Although we have grown to 112 members as of June 2007, the bigger FDA Alliance is, the stronger it will be when it talks to Congress and the media about FDA's needs. So we need to make it bigger and wider. It's important that people make the commitment to stand up for these funding issues and become part of the effort to strengthen FDA.
Q: You have a lot of different voices in your organization. How do you balance their views?
A: That is an inherent challenge. Although we represent organizations with a broad range of interests and concerns, we are devoted to just a single mission. And that single mission is one on which our members are unanimous. The agency needs to be strengthened with more resources. We are careful not to get into policy issues that sometimes appear to be derivative from the budget issues. Those would wind up dividing our membership. We are sticking with one focused mission and it deserves all the attention we can give it.